The Risk of Missing a Safety Signal

Today’s medical monitors require visibility across data sources, CDISC domains, and access to dynamic analyses, but clinical safety data can be difficult to navigate even with these capabilities. The specific needs of medical monitors performing in-stream safety review remind us that all data challenges are not created equal. Medical monitors can’t afford to hunt for specific subjects of interest, rely on manual tracking of the line listing review process, or invest the time to apply generic analytics capabilities to their day-to-day tasks.

In-Stream Safety Review: Vital Challenges

With the staggering complexity and volume of clinical trial data, the risk of missing a safety signal for medical monitors and safety review teams is growing exponentially. In a recent informal survey, 37% of respondents cited the risk of missing a safety signal as their single greatest challenge in medical review, followed by slow decision making and the high cost of supporting analytics infrastructure. This risk can place organizations in danger of a delayed or rejected submission or even a market withdrawal, while compromising the safety of trial subjects.

Faster Review, Decreased Risk, Lower Cost

The key to getting submission ready faster is speeding the time to review, collaborate, and make decisions on data. Signals Medical Review allows you to cut through the noise to go straight to the subjects of interest, and analyze data for those subjects with exactly the visual analytics you need.